MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-09 for CABLES, GA275A5.0-90-G 2A275A50N0 manufactured by Integra Luxtec, Inc..
[1562492]
The customer reports that on "(b)(6) , 2010, a luxtec lx300 xenon light source, a (b)(6) luxtec light cable and a luxtec lighted breast retractor (unk pn) were being used for illumination during a breast augmentation surgery. There were sterile drapes surrounding the surgical site and under the drapes was a warming blanket. The lx300 light source was set to allow the maximum amount of light into the light cable. At the end of the procedure, the light source was switched off and the light cable was removed from the light source. The retractor was removed from the light cable. The end of the light cable that connects to the retractor was immediately placed on the drape (no time allowed for the cable to cool) and caused 5 or 6 small holes in the drape, jeopardizing the sterile field. Because a blanket was underneath the drape, no injury occurred. "
Patient Sequence No: 1, Text Type: D, B5
[8727676]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221336-2010-00003 |
| MDR Report Key | 1773193 |
| Report Source | 05 |
| Date Received | 2010-07-09 |
| Date of Report | 2010-07-09 |
| Date of Event | 2010-05-25 |
| Date Mfgr Received | 2010-06-18 |
| Date Added to Maude | 2011-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLES, GA275A5.0-90-G |
| Generic Name | CABLES |
| Product Code | EQH |
| Date Received | 2010-07-09 |
| Catalog Number | 2A275A50N0 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LUXTEC, INC. |
| Manufacturer Address | WEST BOYLSTON MA 01583 US 01583 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-09 |